Is Melatonin legal in Romania?

Formal status

There is no EU-harmonised rule for melatonin. It sits outside the cannabinoid framework entirely and is governed nationally, with limits ranging from 0.3 mg in Belgium to 2 mg in Spain and no limit at all in several member states. The one EU-level figure is the authorised health claim in Regulation (EU) 432/2012, conditional on 1 mg per quantified portion.

Romania sets no national maximum for melatonin and has not reclassified it as a medicine. Food supplements are placed on the market under Law 56/2021 through notification to the Ministry of Health, and no national list of restricted other substances carrying a melatonin limit was identified.

Romanian practice is openly permissive well above our dose. Melatonin is sold without prescription through the major national pharmacy chains at 5 mg per tablet - five times ours - from Romanian manufacturers as well as imported brands.

Do we sell here?

Not at the moment.

Romania sets no national limit on melatonin, and Romanian pharmacies sell it without prescription at 5 mg per tablet - five times our dose. Our 1 mg is comfortably inside anything Romania requires, and it matches the amount the EU's own authorised sleep claim is built on.

Whether we ship to Romania is a separate question, decided by the rules on CBD rather than by melatonin. Our CBD page for Romania sets that out.

Outlook

Romania is among the more permissive melatonin markets in the EU and shows no sign of tightening.

If the direction of travel elsewhere in Europe eventually reaches Romania - Greece capped supplements at 1 mg in 2024, the Netherlands treats 0.3 mg and above as a medicine - a 1 mg dose would still sit inside every national cap currently in force anywhere in the EU bar those two. That makes this one of the more durable parts of the picture.

Ingredients

Browse legality of our other ingredients in Romania.